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NCT Number: NCT03753399

Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study

This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
  • 2.Pathological stage II or stage III；
  • 3.Without tumor recurrence confirmed by image examination;
  • 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
  • 5.Age:18~75 years old；
  • 6.ECOG score≤ 2；
  • 7. Normal organs function, including: 7.1 Bone marrow function: absolute neutrophil count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/L,hemoglobin (Hb)≥90g/L; 7.2 Kidney function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate (Ccr)≥60ml/min； 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN；
  • 8. Can understand the study well and finish the questionnaires in this study;
  • 9. With the written informed consent.

Exclusion criteria

  • 1. Can not finish the baseline assessment;
  • 2. Needle phobia;
  • 3. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
  • 4. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
  • 5. Implanted with heart pacemaker;
  • 6. Has accepted neoadjuvant radiotherapy before surgery;
  • 7. Planning to accept adjuvant radiotherapy after surgery;
  • 8. With active infection;
  • 9. Acupuncture treatment within the previous 6 weeks;
  • 10.Pregnant or lactating women.

Treatment and study plan

Acupuncture

Procedure

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

Primary outcomes

  1. FACT-Gastric Trial Outcome Index (TOI)

    Time frame: At the end of Cycle 3 (each cycle is 21 days)

    FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.

  2. Chinese version of Edmonton symptom assessment scale (C-ESAS)

    Time frame: At the end of Cycle 3 (each cycle is 21 days)

    Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.

  3. Average trajectory of FACT-Gastric TOI over time

    Time frame: Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).

    FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.

  4. Average trajectory of C-ESAS over time

    Time frame: Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)

    Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Adverse events will be assessed during the period of 3 cycles of treatment (21 days for each cycle), since the date of randomization. Adverse events will be recorded once any side effect happens.

    Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.

  2. Adherence to chemotherapy

    Time frame: At the end of 3 cycles of treatment (21 days for each cycle).

    Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy

  3. Concentration of Inflammatory factors in plasma detected with liquid chip

    Time frame: At the end of 3 cycles of treatment (21 days for each cycle).

    Plasma will be stored at -80℃. Inflammatory factors in plasma will be detected using a liquid chip panel when all patients have finished treatment. the panel is planned to contain 45 inflammatory factors and cytokines, including BDNF, EGF, Eotaxin, FGF-basic, GM-CSF, GROα, HGF, IFNγ, IFNα, IL-1RA, IL-1β, IL-1α, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1α, MIP-1β, NGFβ, PDGF-BB, PLGF, RANTES, SCF, SDF1α, TNFα, TNFβ, VEGF-A, VEGF-D. The panel may be changed at detection according to possible new public articles or reports.

  4. Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry

    Time frame: At the end of 3 cycles of treatment (21 days for each cycle).

    Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry

  5. Concentration of Circulating CD8+ T lymph cells detected using flow cytometry

    Time frame: At the end of 3 cycles of treatment (21 days for each cycle).

    CD8+ T lymph cells in peripheral blood will be detected using flow cytometry

  6. Number of Circulating tumor cells detected using microfluidic chip

    Time frame: At the end of 3 cycles of treatment (21 days for each cycle).

    Circulating tumor cells in peripheral blood will be detected using microfluidic chip

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Collaborators

  • Affiliated Hospital of Nanjing University of Chinese Medicine
  • First Affiliated Hospital, Sun Yat-Sen University

Registry information

Official study title

Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2018
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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